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Combination Chemotherapy in Treating Patients With Primary Peritoneal or Stage III Epithelial Ovarian Cancer Clinical Trials Info presented on Clinical Trials Search is not intended to be a substitute for certified medical advice, visits or professional assistance using a real physician. We are not physicians. Always consult your dr. about Combination Chemotherapy in Treating Patients With Primary Peritoneal or Stage III Epithelial Ovarian Cancer conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Combination Chemotherapy in Treating Patients With Primary Peritoneal or Stage III Epithelial Ovarian Cancer Clinical research trials and Combination Chemotherapy in Treating Patients With Primary Peritoneal or Stage III Epithelial Ovarian Cancer health trials happen in many of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new drugs. The function of the studies / projects is to resolve particular human medical questions. Clinical trials are a popular manner for mDs, government agencies, and private sector corporations to discover remedies for all varieties of circumstances, like Combination Chemotherapy in Treating Patients With Primary Peritoneal or Stage III Epithelial Ovarian Cancer. Combination Chemotherapy in Treating Patients With Primary Peritoneal or Stage III Epithelial Ovarian Cancer Clinical Trials and other clinical trials allow volunteers to obtain healthcare treatment options before they are available to the masses. Some times the participants undergo professional assistance for free of charge, and occasionally they are paid for their time. Sometimes there is a cost for a Combination Chemotherapy in Treating Patients With Primary Peritoneal or Stage III Epithelial Ovarian Cancer clinical trial. Human subjects often get the best healthcare available for their Combination Chemotherapy in Treating Patients With Primary Peritoneal or Stage III Epithelial Ovarian Cancer condition. Dangers are a reality, however, and may include additional or frequent mD visits, healthcare dangers (potentially life-jeopardising), and/or the treatment being ineffectual. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "C" Clinical Trials Conditions > Combination Chemotherapy in Treating Patients With Primary Peritoneal or Stage III Epithelial Ovarian Cancer  Combination Chemotherapy in Treating Patients With Primary Peritoneal or Stage III Epithelial Ovarian Cancer
Combination Chemotherapy in Treating Patients With Primary Peritoneal or Stage III Epithelial Ovarian Cancer
For Condition: ovarian mucinous cystadenocarcinoma,ovarian serous cystadenocarcinoma,peritoneal cavity cancer,Brenner Tumor,Quality of Life,recurrent ovarian epithelial cancer,ovarian undifferentiated adenocarcinoma,ovarian endometrioid adenocarcinoma,ovarian mixed epithelial carcinoma,stage 3 ovarian epithelial cancer,ovarian clear cell cystadenocarcinoma
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Gynecologic Oncology Group
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving drugs in different ways may kill more tumor cells. It is not yet known whether intravenous two-drug combination chemotherapy is more effective than intravenous and intraperitoneal infusions of three-drug combination chemotherapy for treating primary peritoneal or stage III epithelial ovarian cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of intravenous two-drug combination chemotherapy with intravenous and intraperitoneal three-drug combination chemotherapy in treating patients who have primary peritoneal or stage III epithelial ovarian cancer.
Details: OBJECTIVES: I. Compare pathological response, recurrence-free interval, and survival in patients with optimal stage III epithelial ovarian cancer or primary peritoneal carcinoma receiving intravenous (IV) paclitaxel and cisplatin vs IV paclitaxel and intraperitoneal (IP) cisplatin plus IP paclitaxel. II. Compare the toxic effects and complications of these 2 treatment regimens in these patients. III. Determine the frequency and prognostic significance of BRCA1 and BRCA2 mutations in these patients. IV. Determine the effect of non-genetic risk factors on the course of disease in BRCA1- and BRCA2-related ovarian cancer or primary peritoneal carcinoma. V. Compare the quality of life of these patients receiving these treatments. PROTOCOL OUTLINE: This is a randomized study. Patients are stratified according to gross residual disease (present vs absent) and whether second-look surgery will be performed at the end of treatment (yes vs no). Blood is drawn for BRCA mutation analysis and DNA extraction before the start of chemotherapy, but after randomization. Patients are randomized to one of two treatment arms. Patients in arm I receive IV paclitaxel by 24-hour infusion on day 1 followed by IV cisplatin on day 2. Patients in arm II receive IV paclitaxel by 24-hour infusion on day 1 followed by intraperitoneal (IP) cisplatin on day 2, plus IP paclitaxel on day 8. Treatment for both arms repeats every 3 weeks for a total of 6 treatment courses. Following chemotherapy, second look surgery is performed if selected by the patient. Quality-of-life assessments are performed prior to randomization, prior to course 4, 3-6 weeks after the completion of course 6 and prior to second look surgery if selected, 6 months after treatment is completed, and 12 months after treatment is completed. Patients are followed every 3 months for 2 years, then every 6 months thereafter. PROJECTED ACCRUAL: Approximately 384 patients will be accrued for this study within 16 months.
Eligibility:
Study Type: Interventional, Educational/Counseling/Training
Minimum Age/Maximum Age: /
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically proven primary peritoneal carcinoma or optimal (no greater than 1 cm residual disease) stage III epithelial ovarian carcinoma with the following epithelial cell types: Serous adenocarcinoma;Endometrioid adenocarcinoma; Mucinous adenocarcinoma; Undifferentiated carcinoma; Clear cell adenocarcinoma ;Mixed epithelial carcinoma; Transitional cell carcinoma; Malignant Brenner's Tumor; Adenocarcinoma; NOS - Prior surgery for ovarian/peritoneal carcinoma required - No epithelial ovarian carcinoma of low malignant potential (borderline carcinoma) --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: No prior chemotherapy - Endocrine therapy: Not specified - Radiotherapy: No prior radiotherapy - Surgery: See Disease Characteristics; No more than 6 weeks since prior surgery --Patient Characteristics-- - Age: Not specified - Performance status: GOG 0-2 - Life expectancy: Not specified - Hematopoietic: WBC at least 3,000/mm3; Platelet count at least 100,000/mm3 - Hepatic: Bilirubin no greater than 1.5 times normal; SGOT no greater than 3 times normal; Alkaline phosphatase no greater than 3 times normal; No acute hepatitis - Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No unstable angina; No myocardial infarction within prior 6 months; Patients with abnormal cardiac conduction are eligible if disease stable for at least 6 months - Other: No septicemia or severe infection; No severe gastrointestinal bleeding No other invasive malignancy within past 5 years except nonmelanoma skin cancer; Any previous cancer treatment must not contraindicate this protocol therapy
Total Enrollment:
Location and Contact Information:
Overall Study Official:
DeborahArmstrong, Study Chair, Gynecologic Oncology Group
University of Colorado Cancer Center
Denver, Colorado, 80262
United States
Indiana University Cancer Center
Indianapolis, Indiana, 46202-5265
United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612
United States
Chao Family Comprehensive Cancer Center
Orange, California, 92868
United States
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, 01655
United States
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, 89106
United States
Cancer Center of Albany Medical Center
Albany, New York, 12208
United States
CCOP - Evanston
Evanston, Illinois, 60201
United States
University of Chicago Cancer Research Center
Chicago, Illinois, 60637
United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, 43210
United States
State University of New York Health Science Center at Brooklyn
Brooklyn, New York, 11203
United States
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
Winston Salem, North Carolina, 27157-1082
United States
Abington Memorial Hospital
Abington, Pennsylvania, 19001
United States
Medicine Branch
Bethesda, Maryland, 20892
United States
Rush-Presbyterian-St. Luke's Medical Center
Chicago, Illinois, 60612
United States
Lombardi Cancer Center, Georgetown University
Washington D.C., District of Columbia, 20007
United States
CCOP - Montana Cancer Consortium
Billings, Montana, 59101
United States
Johns Hopkins Oncology Center
Baltimore, Maryland, 21231
United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307-5000
United States
University of Washington Medical Center
Seattle, Washington, 98195-6043
United States
Washington University School of Medicine
St. Louis, Missouri, 63110
United States
CCOP - Atlanta Regional
Atlanta, Georgia, 30342-1701
United States
North Shore University Hospital
Manhasset, New York, 11030
United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201
United States
University of Oklahoma College of Medicine
Oklahoma City, Oklahoma, 73190
United States
Cleveland Clinic Cancer Center
Cleveland, Ohio, 44195
United States
CCOP - Baptist Cancer Institute
Memphis, Tennessee, 38117
United States
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, 19104
United States
CCOP - Columbia River Program
Portland, Oregon, 97213
United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, 27599-7295
United States
Medical University of South Carolina
Charleston, South Carolina, 29425-0721
United States
Women's Cancer Center
Palo Alto, California, 94304
United States
USC/Norris Comprehensive Cancer Center
Los Angeles, California, 90033-0800
United States
University of Minnesota Cancer Center
Minneapolis, Minnesota, 55455
United States
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
United States
University of Alabama Comprehensive Cancer Center
Birmingham, Alabama, 35294
United States
Emory University Hospital - Atlanta
Atlanta, Georgia, 30322
United States
MBCCOP - Hawaii
Honolulu, Hawaii, 96813
United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
United States
Morristown Memorial Hospital
Morristown, New Jersey, 07962-1956
United States
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, 19107
United States
Tom Baker Cancer Center - Calgary
Calgary, Alberta, T2N 4N2
Canada
Albert B. Chandler Medical Center, University of Kentucky
Lexington, Kentucky, 40536-0084
United States
Ireland Cancer Center
Cleveland, Ohio, 44106-5065
United States
Barrett Cancer Center, The University Hospital
Cincinnati, Ohio, 45219
United States
Tacoma General Hospital
Tacoma, Washington, 98405
United States
Cancer Center, University of Virginia HSC
Charlottesville, Virginia, 22908
United States
CCOP - Greater Phoenix
Phoenix, Arizona, 85006-2726
United States
St. Barnabas Medical Center
Livingston, New Jersey, 07039
United States
CCOP - Kansas City
Kansas City, Missouri, 64131
United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030
United States
Cooper Hospital/University Medical Center
Camden, New Jersey, 08103
United States
Radiation Oncology Branch
Bethesda, Maryland, 20892
United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216-4505
United States
CCOP - Upstate Carolina
Spartanburg, South Carolina, 29303
United States
Brookview Research, Inc.
Nashville, Tennessee, 37203
United States
CCOP - Central Illinois
Decatur, Illinois, 62526
United States
State University of New York Health Sciences Center - Stony Brook
Stony Brook, New York, 11790-7775
United States
CCOP - Sooner State
Tulsa, Oklahoma, 74136
United States
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, 68131
United States
University of Rochester Cancer Center
Rochester, New York, 14642
United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
United States
Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
United States
Simmons Cancer Center - Dallas
Dallas, Texas, 75235-9154
United States
CCOP - Ann Arbor Regional
Ann Arbor, Michigan, 48106
United States
Additional Information:
Study ID Numbers: CDR0000066273; GOG-172
Study Start Date: March 1998
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003322
Other Recurrent Ovarian Epithelial Cancer Studies:
1. Tamoxifen Compared With Thalidomide in Treating Women With Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
2. Combination Chemotherapy in Treating Patients With Previously Untreated, Newly Diagnosed Epithelial Tumors
3. Bevacizumab in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer or Primary Peritoneal Cancer
4. TLK286 in Treating Patients With Advanced Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
5. Radiation Therapy to the Abdomen Plus Docetaxel in Treating Patients With Recurrent or Persistent Advanced Ovarian, Peritoneal, or Fallopian Tube Cancer
Related Studies:
Other recurrent ovarian epithelial cancer Clinical Trials
Other New York Clinical Trials
Other Manhasset Clinical Trials
Combination Chemotherapy in Treating Patients With Primary Peritoneal or Stage III Epithelial Ovarian Cancer
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